Hearing loss, which may be due to many different causes, is generally of two types, conductive and sensorineural. Of these types, conductive hearing loss occurs where the normal mechanical pathways for sound to reach the hair cells in the cochlea are impeded, for example, by damage to the ossicles. Conductive hearing loss may often be helped by use of conventional hearing aids, which amplify sound so that acoustic information does reach the cochlea and the hair cells.
In many people who are profoundly deaf, however, the reason for deafness is sensorineural hearing loss. This type of hearing loss is due to the absence of, or destruction of, the hair cells in the cochlea which transduce acoustic signals into nerve impulses. These people are thus unable to derive suitable benefit from conventional hearing aid systems, because there is damage to or absence of the mechanism for nerve impulses to be generated from sound in the normal manner.
It is for this purpose that cochlear implant systems have been developed. Such systems bypass the hair cells in the cochlea and directly deliver electrical stimulation to the auditory nerve fibres, thereby allowing the brain to perceive a hearing sensation resembling the natural hearing sensation normally delivered to the auditory nerve. U.S. Pat. No. 4,532,930, the contents of which are incorporated herein by reference, provides a description of one type of traditional cochlear implant system.
Cochlear implant systems have typically consisted of two key components, namely an external component commonly referred to as a processor unit, and an implanted internal component commonly referred to as a stimulator/receiver unit. Traditionally, both of these components have cooperated together to provide the sound sensation to an implantee. The external component has traditionally consisted of a microphone for detecting sounds, such as speech and environmental sounds, a speech processor that converts speech detected by the microphone into a coded signal, a power source such as a battery, and an external antenna transmitter coil.
The coded signal output by the speech processor is transmitted transcutaneously to the implanted stimulator/receiver unit situated within a recess of the temporal bone of the implantee. This transcutaneous transmission occurs through use of an inductive coupling provided between the external antenna coil which is positioned to communicate with an implanted antenna receiver coil provided with the stimulator/receiver unit. This communication serves two essential purposes, firstly to transcutaneously transmit the coded sound signal and secondly to provide power to the implanted stimulator/receiver unit. Conventionally, this link has been in the form of a radio frequency (RF) link, but other such links have been proposed and implemented with varying degrees of success.
The implanted stimulator/receiver unit has typically included the antenna receiver coil that receives the coded signal and power from the external processor component, and a stimulator that processes the coded signal and outputs a stimulation signal to an intracochlea electrode assembly which applies the electrical stimulation directly to the auditory nerve producing a hearing sensation corresponding to the original detected sound. As such, the implanted stimulator/receiver device has been a relatively passive unit that has relied on the reception of both power and data from the external unit to perform its required function.
The external componentry of the cochlear implant has been traditionally carried on the body of the implantee, such as in a pocket of the implantee's clothing, a belt pouch or in a harness, while the microphone has been mounted on a clip mounted behind the ear or on a clothing lapel of the implantee. As such, traditional systems have required a large amount of external componentry and electrical leads to enable the system to function properly.
More recently, due in the main to improvements in technology, the physical dimensions of the speech processor have been able to be reduced, thereby allowing the external componentry to be housed in a small unit capable of being worn behind the ear of the implantee. This unit has allowed the microphone, power unit and the speech processor to be housed in a single unit capable of being discretely worn behind the ear. Despite the development of these so-called behind-the-ear (BTE) units, there still exists the need for an external transmitter coil to be positioned on the side of the implantee's head to allow for the transmission of the coded sound signal from the speech processor and power to the implanted stimulator unit. This need for a transmitter coil further requires leads and additional componentry which have added to the complexity of such systems as well as being quite noticeable. Nevertheless, the introduction of a combined unit capable of being worn behind the ear has greatly improved the visual and aesthetic aspects for cochlear implant implantees.
While traditional cochlear implants have proven very successful in restoring hearing sensation to many people, the construction of the conventional implant with its external electronic components has limited the circumstances in which the implant can be used by an implantee. For example, implantees cannot wear the devices while showering or engaging in water-related activities. Most implantees also do not use the devices whilst asleep due to discomfort caused by the presence of the BTE unit or the external transmitter coil and the likelihood that the alignment between the external transmitter coil and the internal receiver coil will be lost due to movements during sleep. With the increasing desire of cochlear implant implantees to lead a relatively normal life, at least the equivalent of a naturally hearing person, there exists a need to provide a system which allows for total freedom with improved simplicity and reliability, at least at those times when desired by the implantee.
Because of this need, fully implantable systems that do not require external componentry for operation for at least some of their operating life, have been postulated, although none have as yet been commercially available.
An example of one type of system which has been proposed is described in U.S. Pat. No. 6,067,474 by Advanced Bionics Corporation and Alfred E Mann Foundation for Scientific Research. This system attempts to provide all system components implanted in the implantee, and includes a microphone placed in the ear canal which communicates with a conventionally positioned stimulator unit via a conventional RF link. There is further described a battery unit which can be integral with the stimulator unit or separate therefrom. Such a system provides further complications as it requires surgical implantation of a number of components and hence complicates the surgical procedure. The system also maintains the need for a RF link during normal operation between implanted components which increases overall power requirements of the system and unnecessarily drains the internal battery supply. Also, with remotely implanted transmitters required to communicate between internal components, there is also the possibility of increased likelihood of system failure due to component malfunction and as such the procedure required to correct such a device failure becomes further complicated.
Another proposed device is described in International Patent Application No WO 01/39830 to EPIC Biosonics Inc. This system also employs a microphone positioned in the ear canal and an extendible lead connecting the microphone to the implanted stimulator. This proposed system therefore inherits the drawbacks of the system mentioned above as well as introduces a complicated design to the stimulator unit that requires a revised surgical procedure to implant the device.
Generally, the proposed totally implanted cochlear implants suggested to this date, have failed to propose a system which provides the added freedom of a totally implanted device without substantially complicating the surgical procedure and increasing the complexity of the device. Each of the suggested proposals would greatly increase the number of components required to be implanted and in turn would require a further complicated surgical procedure, which may in turn negate the benefits that such a device may provide. Added to this, the increased system complexity and the need to implant connecting leads from the remote components to the implant stimulator, also adds an increased risk of component failure, which again may negate the very benefits that such systems offer.
In the area of hearing aids that deliver mechanical stimulation to the middle ear to amplify the sound detected by the naturally present hair cells in the cochlea, totally implanted devices have also been proposed. International Patent Application No WO 97/44987 to Lesinski and Neukermans, describes a microphone which can be used in such a hearing aid application. The purpose of this particular application is to detect sound and directly apply this sound via mechanical vibrations which can be detected by the perilymph fluid causing a hearing sensation to the intact receptor cells in the cochlea.
The requirements of a hearing aid differ greatly from those of a cochlear implant. In a cochlear implant, the recipient does not possess the functions to detect mechanical vibrations of the perilymph fluid in the cochlear as sound, and as such the stimulation must be delivered in the form of electrical impulses directly to the nerves within the cochlea. In this event, the processing and power requirements of a cochlear implant are significantly different from those of a hearing aid. As the electrode array of a cochlea implant is inserted into the sensitive structures of the cochlea, a cochlea implant is also not readily explantable in the same manner as an implantable hearing aid.
It is also important to recognise that totally implanted hearing aids are designed to operate totally as an implantable device, with the only external componentry used being an external battery charger. Therefore, the implanted microphone is the sole microphone used by the device.
With the above background in mind, there is a need to provide a totally implanted cochlear implant system which does not require external componentry to operate at least for a specific period of time and which provides all components in a single unit able to be implanted by conventional surgical procedures.
Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is solely for the purpose of providing a context for the present invention. It is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present invention as it existed before the priority date of each claim of this application.